HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
TORISEL® (temsirolimus)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
TORISEL® Quick Finder
1 INDICATIONS AND USAGE
TORISEL is indicated for the treatment of advanced renal cell carcinoma.
2 DOSAGE AND ADMINISTRATION
2.1 Advanced Renal Cell Carcinoma
The recommended dose of TORISEL for advanced renal cell carcinoma is 25 mg administered as an...
3 DOSAGE FORMS AND STRENGTHS
TORISEL (temsirolimus) is supplied as a kit consisting of the following:
TORISEL (temsirolimus) injection (25 mg/mL). The TORISEL vial contains temsirolimus at a concentration of 25 mg/mL....
4 CONTRAINDICATIONS
TORISEL is contraindicated in patients with bilirubin >1.5×ULN [see Warnings and Precautions (5.2)].
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity/Infusion Reactions
Hypersensitivity/infusion reactions, including but not limited to flushing, chest pain, dyspnea,...
7 DRUG INTERACTIONS
7.1 Agents Inducing CYP3A Metabolism
Co-administration of TORISEL with rifampin, a potent CYP3A4/5 inducer, had no significant effect on...
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings in...
10 OVERDOSAGE
There is no specific treatment for TORISEL intravenous overdose. TORISEL has been administered to patients with cancer in phase 1 and 2 trials with repeated intravenous doses as high as 220 mg/m...
11 DESCRIPTION
Temsirolimus, an inhibitor of mTOR, is an antineoplastic agent.
Temsirolimus is a white to off-white powder with a molecular formula of C56H87NO...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Temsirolimus is an inhibitor of mTOR (mammalian target of rapamycin). Temsirolimus binds to an intracellular protein...
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies have not been conducted with temsirolimus. However,...
14 CLINICAL STUDIES
A phase 3, multi-center, three-arm, randomized, open-label study was conducted in previously untreated patients with advanced renal cell carcinoma (clear cell and non-clear cell histologies). The...
15 REFERENCES
- 1.
- OSHA Hazardous Drugs. OSHA. https://www.osha.gov/SLTC/hazardousdrugs/index.html.
16 HOW SUPPLIED/STORAGE AND HANDLING
NDC 0008-1179-01 TORISEL (temsirolimus) injection, 25 mg/mL.
Each kit is supplied in a...
17 PATIENT COUNSELING INFORMATION
Allergic (Hypersensitivity/Infusion) Reactions
Patients should be informed of the possibility of serious...
Resources
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
(800)-332-1088.